TB Technical Instructions for Panel Physicians: Implications for US-Practitioners

Slide 1:

Medical Update

November 28, 2012

There is the logo of the New Jersey Medical School Global Tuberculosis Institute.

There is a photo of an immigration officer with an airplane in the background.

Sponsored by the New Jersey Medical School Global Tuberculosis Institute

Slide 2:

Objectives

Upon completion of this seminar, participants should be able to:

· Describe the purpose and use of the TB technical instructions in the medical evaluation of persons emigrating to the United States (US)

· List the changes to the TB technical instructions to clarify their use in the examination of immigrants and refugees

· Explain how to implement the TB technical instructions to appropriately provide related medical consultation

· Apply the TB technical instructions to the medical follow-up of immigrants and refugees arriving in the US

Slide 3:

Faculty

Phil Lowenthal, MPH

Tuberculosis Control Branch

California Department of Public Health

Sundari Mase MD, MPH Field Services and Evaluation Branch Division of Tuberculosis Elimination Centers for Disease Control and Prevention

Drew L. Posey, MD, MPH

Immigrant, Refugee, and Migrant Health Branch

Division of Global Migration and Quarantine

Centers for Disease Control and Prevention

Slide 4:

Agenda

· Background and Overview of Technical Instructions

—Sundari Mase, MD, MPH

· Implementation and Roll Out of Technical Instructions

—Drew Posey, MD, MPH

· Case Presentations

— Sundari Mase, MD, MPH

· Discussion

Slide 5:

Why Were the Tuberculosis Technical Instructions (TI) Updated?1991 Versus Culture and Directly Observed Therapy Tuberculosis TI (formerly 2007 TB TI)

Sundari Mase MD, MPH

Medical Team Lead

CDC/DTBE/FSEB

Division of Global Migration and Quarantine/Division of TB Elimination

Slide 6:

Learning Objectives

After this session, you should be able to:

· Describe reasons for changing from 1991 to Culture and Directly Observed Therapy TB Technical Instructions (2007) TI

· List changes in Culture and Directly Observed Therapy TB technical Instructions (2007)

Slide 7:

Background

· Each year, approximately 400,000 immigrants and 50,000 refugees enter the United States

· The Division of Global Migration and Quarantine (DGMQ) has regulatory authority to stipulate the requirements of the overseas medical examination via Technical Instructions

· The Bureau of Populations, Refugees, and Migration (BPRM) is the State Department bureau responsible for refugee resettlements

· BPRM has contracted the International Organization for Migration (IOM) to perform the medical screening for approximately 80% of the refugees.

· The initial Technical Instructions for Tuberculosis (TB TI) was issued in 1991

Slide 8:

Rationale for Overseas Screening and Domestic Follow-up

· Overseas Panel Physicians screen TB suspects using DGMQ TIs

o Restrict entry of infectious TB cases

o Facilitate entry of the rest to allow U.S. entry, evaluation and treatment per ATS/CDC standards

· US Health Department follow-up evaluation and treatment of noninfectious cases is cost-effective

Slide 9:

Background – Hmong Outbreak

· December 2003, the U.S. Department of State approved resettlement of over 15,000 Laotian Hmong refugees to the United States.

· Medical screening started in February 2004 and refugees began arriving June 2004

· January 2005

o CDC notified of 31 active TB cases in CA out of 5837 refugees (case rate = 700/100,000); 50% of culture confirmed cases (7) MDR-TB

o Resettlement halted

o Investigations Thailand and California

Slide 10:

There is a photo of a refugee camp.

Slide 11:

TB Technical Instructions (TI)

Slide 12:

Table with title, 1991 TI

There are 2 columns; the left column is labeled as procedure and the right column is labeled as 1994 TB TI.

First row: The procedure is skin test (TST) and is not in the 1991 TB TI

Second row: The procedure is chest x-ray and in the 1991 TB TI it is for those greater than or equal to 15 years of age.

Third row: The procedure is laboratory and the 1991 TB TI has limited requirements.

Fourth row, the procedure is TB treatment and in the 1991 TB TI, DOT is not necessary.

Slide 13:

This is an algorithm titled 1991 TI: TB evaluation for applicants greater than or equal to 15 years of age. It starts with performing a chest radiograph. If the chest radiograph shows inactive TB, the patient is considered as Class B2. He or she has travel valid for 6 months. If smears are negative then the patient is considered non-infectious and class B1. If the chest radiograph shows active TB, 3 AFB smears are done. If all of the smears are negative, the patient is considered to be non-infectious, class B1. If at least one smear is positive, the patient is considered to be infectious class A. There is a limited treatment requirement with no DOT and a class A waiver. If the chest radiograph shows no TB, the patient is in no class, and has travel valid for 12 months.

Slide 14:

Technical Instruction Revision

· CDC began revising TB portion of 1991 TI in 2005

· Scientific literature reviewed

· Input from U.S. Tuberculosis Community (TB TI Working Group):

o Advisory Council for the Elimination of Tuberculosis (ACET)

o National Tuberculosis Controllers Association (NTCA)

o STOP TB USA

Slide 15:

World-Wide TB Statistics

· 1/3 of world infected

· 9.3 million cases of active TB

· 138 million deaths

Slide 16:

World map titled, Estimated TB Incidence rates, 2010

There is a caption at the bottom of the picture that says: The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city, or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.

The map shows 0 to 24 estimated TB cases per hundred thousand in the United States, Canada, Mexico, Iceland, the Caribbean with the exception of the Dominican Republic, Australia, Saudi Arabia, Japan, Egypt, Chile, Uruguay, and most of Western Europe. There are 25 to 49 estimated cases per 100,000 in Latin America, Libya, Yemen, Brazil, Columbia, Venezuela, Paraguay, Portugal, Argentina, and Haiti. There are 50 to 99 estimated TB cases per hundred thousand in China, South Korea, Morocco, Algeria, Mali, Burkina Faso, Rwanda, Burundi, Ghana, Iraq, Uzbekistan, Sri Lanka, Brunei, Bosnia and Herzegovina, and Laos. There are 100 to 299 estimated TB cases per hundred thousand in Russian Federation, Senegal, Ghana, Cote d’Ivoire, Niger, Chad, Sudan, Eritrea, Ethiopia, Somalia, Uganda, Kenya, UR Tanzania, Madagascar, Malawi, India, Pakistan, Bangladesh, Nepal, Burma, Bhutan, Indonesia, Malaysia, New Guinea (Indonesia), Borneo, Vietnam, Philippines, Thailand, Kazakhstan, Mongolia, Tajikistan, Turkmenistan, Kyrgyzstan, and Afghanistan. There are greater than or equal to 300 estimated TB cases per hundred thousand in New Guinea, North Korea, Cambodia, Philippines, Djibouti, Togo, Mauritania, Central African Republic, Gabon, Congo, DR Congo, Angola, Zambia, Mozambique, Namibia, Botswana, Swaziland, Lesotho, South Africa, and Zimbabwe. There is no estimate of a case rate for Greenland.

Slide 17:

Bar and line graphs titled, Tuberculosis Cases, United States, 1993-2009.

The graph shows that US-born cases have declined between 1993-2009 from about 18,000 cases to about 4,000 cases. Foreign-born cases have fluctuated slightly but have been around 8,000 cases each year. The percent of total cases which are foreign-born has increased over time from about 30% to 60%.

Slide 18:

Vietnam Immigrant Study

· Performed on U.S. immigrant applicants using 1991 Technical Instructions AND TB cultures

· 1,179 abnormal chest radiographs

o 82 (7%) positive sputum smears

o 183 (15.5%) positive sputum cultures

· Sensitivity of 1991 Technical instructions

o 34%

· Missing ~ 2/3 of TB cases (culture as gold standard)

The footnote reads: Maloney SM, et al. Arch Intern Med 2006; 166:234-40.

Slide 19:

TI Revision Collaborators

· U.S. Department of State

· CDC Division of Tuberculosis Elimination (DTBE)

· U.S. Agency for International Development (USAID)

· International Organization for Migration (IOM)

· Ministries of Health

· Other countries performing overseas pre-immigration tuberculosis screening

· Panel physicians

· Applicants

There are logos of the United States Department of State, USAID, CDC, and IOM.

Slide 20:

Culture and DOT TB TI

Changes

· Tuberculin skin test or interferon gamma release assay (IGRA) in applicants 2-14 years of age in countries with World Health Organization (WHO)-estimated incidence rate of ≥20 per 100,000

o Country of examination

o CXR required if TST ≥ 10 mm or IGRA positive

· Three sputum cultures (and smears) required for applicant with abnormal chest radiograph

Slide 21:

Culture and DOT TB TI

Changes

· Drug susceptibility testing (DST) on positive cultures

· Directly observed therapy (DOT) according to ATS/CDC/IDSA guidelines for pansusceptible smear or culture-positive applicants

o Curry Center guidelines for drug-resistant TB cases

· Reduced validity period of medical examination

o 3 months if Class B1 TB or HIV

§ From date culture result reported

o 6 months otherwise

§ For No TB Class, or Class B2 or B3 TB

§ From date of physical examination

Slide 22:

Culture and DOT TB TI

· Children 10 years of age or less may travel while TB cultures are pending

o If do not meet specific criteria that correlate with infectiousness

o B1 TB classification

· Applicants who undergo TB treatment at a non-CDC approved site must

o Provide specific treatment documentation

o Wait 1 year post-treatment to undergo a repeat immigration medical examination

Slide 23:

No treatment equals no travel (Remain Class A for TB)

Slide 24:

Culture and Directly Observed Therapy TB TI (formerly 2007 TB TI)WHO Incidence ≥20/100,000

Slide 25:

Algorithm titled: 2007 TB TI: Ages 2-14 WHO TB Incidence ≥20/100,000

If the patient is 2 through 14 years of age and you do a TST or IGRA and the result is a TST of less than 10 millimeters or IGRA is negative, there is no classification and the patient can travel within 6 months. If the TST is greater than or equal to 10 millimeters do a chest x-ray. If the chest x-ray is normal, the patient is considered class B2 and should have an LTBI evaluation and can travel within 6 months. Those who are HIV infected who have three negative smears and cultures are “no class” for TB and class B other, HIV infection. They must travel within 3 months of the date the culture result is reported.

If the chest x-ray is suggestive of TB, the patient has signs or symptoms of TB, or HIV infection, there should be three sputum smears and cultures for Mycobacterium tuberculosis. If there is at least one positive smear or culture, the patient has class A TB. If any of the smears cultures positive, then drug susceptibility testing should be performed on the positive culture and the patient would need to be treated according to ATS/CDC/IDSA guidelines by directly observed therapy until therapy is complete and then can travel within the three-month period. If all of the smears and cultures were negative, then the patient has class B1 TB and then could travel within the three-month period.

Slide 26:

Algorithm titled: 2007 TB TI: Age > 15

For patients greater than or equal to 15 years of age, do a chest x-ray. If the chest x-ray is normal, the patient has no TB classification and can travel within 6 months. Those who are HIV infected who have three negative smears and cultures are no class for TB and class B other, HIV infection. They must travel within 3 months of the date the culture result is reported.

If the chest x-ray was suggestive of TB, the patient has signs or symptoms of TB, or HIV infection, there should be three sputum smears and cultures for Mycobacterium tuberculosis. If there is at least one positive smear or culture, the patient has class A TB. If any of the smears cultures positive, then drug susceptibility testing should be performed on the positive culture and the patient would need to be treated to ATS/CDC/IDSA guidelines by directly observed therapy until therapy is complete and then could travel within the three-month period. If all of the smears and cultures were negative, then the patient has class B1 TB and then could travel within the three-month period.

Slide 27:

Algorithm titled: 2007 TB TI WHO TB Incidence ≥20/100,000

This slide show the algorithms from slides 25 and 26 combined on one slide.

Slide 28:

Algorithm titles: Culture and Directly Observed Therapy TB TI (formerly 2007 TB TI)

If the TB rate is >20 per 100,000, persons 2- to 14 years of age, children between two and 14 would have TST or interferon gamma release assay; if it was positive then a chest x-ray.

If the patient was HIV infected or had TB signs or symptoms, he or she would get a chest x-ray and if it is abnormal, would have three sputum smears and cultures. If all smears and cultures are negative, the are Class B1, if one or more are positive, considered to be Class A and they’d have DOT, treatment under Directly Observed Therapy until cured. They could potentially qualify for a Class A waiver which when we listen to the cases I'll get into that.

Slide 29:

Culture and Directly Observed Therapy TB TI (formerly 2007 TB TI) Classifications

Table with 2 columns labeled Class and Status.

First row one reads class as no classification and status as normal.

Second row read class as A and status as tuberculosis disease.

Third row read class as B1 pulmonary and status as abnormal chest x-ray.

Fourth row reads class as B1 extrapulmonary and status as extrapulmonary tuberculosis.

Fifth row read class as B2 and status as LTBI evaluation.

Sixth row reads class B3 and status as contact evaluation.

Slide 30:

DOT Definition

• DOT

o Is an adherence-enhancing treatment strategy

o Standard of care for TB treatment in which a trained health care worker monitors the TB patient as he takes each dose of anti-TB medication.

• Under the Culture and DOT TB TI, DOT must be administered when tuberculosis disease (Class A TB) is present.

o Smear or culture positive

o Clinical diagnosis (minority of cases)

Slide 31:

Table titled 1991 vs. Culture and DOT (2007) TB TI

There are 3 columns labeled procedure, 1991 TB TI and 2007 TB TI

Row 1: Skin test or IGRA is not in the 1991 TB TI. In the 2007 TB TI, it is for persons 2 through 14 years of age if the country TB rate is greater than or equal to 20 per 100,000

Row 2: Chest x-ray in the 1991 TB TI is for persons greater than or equal to 15 years of age. In the 2007 TB TI it is for persons greater than or equal to 15 years of age or if the tuberculin skin test is greater than or equal to 10 millimeters or IGRA is positive

Row 3: For laboratory procedures, in the 1991 TB TI, smears were required and in the 2007 TB TI smears and culture and drug susceptibility testing are required.

Row 4: TB treatment in the 1991 TB TI is not required by DOT and in the 2007 TB TI it required is by DOT using US guidelines until therapy is completed.